difluprednate ophthalmic (Rx)

Frequency Not Defined

Increased IOP

Anterior chamber inflammation

Corneal edema

Conjunctival edema

Blepharitis

Cataract

Optic nerve damage

Abnormal healing (after surgery)

Local irritation

Punctate keratitis

Hyperemia

Punctate keratitis

Decreased visual acuity

Eye pain

Photophobia

Postmarketing Reports

Elevated intraocular pressure

Posterior subcapsular cataract formation

Secondary ocular infection

Perforation of the globe

Contraindications

Most active viral diseases of cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures

Cautions

Use caution in glaucoma, prolonged use may increase IOP (monitor)

May increase risk of cataracts

The use of steroids after cataract surgery may delay healing and increase incidence of bleb formation; perforations, associated with thinning of cornea or sclera, may occur; initial prescription and renewal of medication order beyond 28 days should be made by a physician only after examination of patient with aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining

Employment of corticosteroid medication in treatment of patients with history of herpes simplex requires great caution; use of ocular steroids may prolong course and may exacerbate severity of many viral infections of the eye (including herpes simplex)

Prolonged use of corticosteroids may suppress host response and thus increase hazard of secondary ocular infections; in acute purulent conditions, steroids may mask infection or enhance existing infection; if signs and symptoms fail to improve after 2 days, patient should be re-evaluated

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where steroid has been used or is in use

Not for intraocular administration

Pregnancy Category: C

Lactation: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk. Use caution.

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Antiinflammatory corticosteroid; inhibits inflammatory response including capillary dilation, edema, leukocyte migration, and scar formation

Absorption

Absorption: Negligible absorption

Metabolism: Undergoes deacetylation to active metabolite